The Site performs certain clearinghouse services exclusively for those providers who use BOTOX®, by serving to electronically verify insurance eligibility and research claims statuses of BOTOX® with payers. In addition, the Site processes BOTOX® claim status requests containing a nonstandard format or containing nonstandard data content (specifically Direct Data Entry) into standard transactions. The Site does not route or store any information related to other non-BOTOX® related insurance eligibility, claim statuses or other services beyond what is needed to extract the BOTOX®-related information from data submitted by the provider and to perform the services offered through the Site.
In addition to insurance benefit and claim status research, the Site provides participating providers with additional coding and billing information regarding BOTOX®
to support the appropriate submission of a BOTOX®
Access to Password-Protected Areas
Compliance with Laws
You may not use the Site for any purpose or in any manner that violates any applicable local, state, or federal law or regulation or the law or regulation of any foreign government. You represent and warrant that you have all rights to post and/or submit any data or information through the Site (collectively, "Data"). You agree that you will only submit Data in compliance with the Health Information Portability and Accountability Act of 1996 ("HIPAA"), as amended by, among other authorities, the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act"), and their implementing requlations, and other applicable state or federal privacy laws. You agree that, to the extent required and/or appropriate, you are responsible for obtaining any authorizations, informed consents, and/or other required approvals prior to submitting Data to the Site, and, upon Allergan's request, you agree to present redacted copies of the same to Allergan.
You are responsible for all Data that you upload, post, email or otherwise transmit using the Site. You agree not to use the Site to:
- Upload, post, email, or otherwise transmit any Data that infringes any patent, trademark, trade secret, copyright or other intellectual property right, privacy right, or publicity right of any person or entity;
- Directly or indirectly, intentionally disrupt or interfere with the Site or services in any manner that may materially adversely affect Allergan, Lash or any third party; or
- Upload, post, email or otherwise transmit any material that contains software viruses or any other code, files or programs designed or known to disable, interrupt, or limit the functionality of any computer hardware, computer software, or telecommunications equipment or facilities.
Some payers may not be able to accept HIPAA-compliant transactions or may require additional data elements beyond what is required by law and regulations. Additionally, some payers may not have the ability to electronically provide insurance benefit or claims status information. Because the actions of third parties are beyond our control, it is not the responsibility of Allergan or Lash to provide insurance benefit or claims status information from all payers or to ensure the accuracy of the information provided.
The use of the Site does not replace or supplant any existing or future clearinghouse relationships that you or your practice may have. You are solely responsible for ensuring that your use of the Site does not delay, interrupt, interfere, impact or otherwise alter any existing clearinghouse claims routing or other electronic transactions that occur between you and such other clearinghouses. You agree to that Allergan, Lash, other third party service providers, and our respective affiliates, officers, directors, employees and agents, shall not be responsible or be held liable for any delays, interruptions or other errors that may occur or arise out of any claims, reimbursement, payment or other electronic transactions between you and such other clearinghouses.
The use of the Site does NOT promise or guarantee coverage, payment or reimbursement, in whole or in part, of a claim by a payer or other third parties. You agree that you accept responsibility for all applicable claims and for your use of the Site. Please consult your payer organization with regard to local or actual coverage and reimbursement policies and determination processes.
You should assume that all contents of the Site are copyrighted unless otherwise noted and may not be used except as provided herein and without the express written permission of Allergan. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any Allergan copyright.
All product names, logos, and service marks displayed on the Site that are identified by ® or TM or appearing in type form different from that of the surrounding text (collectively, the "Trademarks") are registered or unregistered trademarks owned by or licensed to Allergan or our affiliates, unless otherwise identified as being owned by another entity. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right, either express or implied, under any patent or Trademark of Allergan or any third party. No use of any Trademark may be made without the prior written authorization of Allergan, except to identify the product or services of the company.
Each person assumes full responsibility and all risks arising from use of the Site. IN NO EVENT SHALL ANY OF ALLERGAN, LASH, OUR RESPECTIVE AFFILIATES, AND ANY OF OUR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, REPRESENTATIVES, INFORMATION PROVIDERS, AND LICENSORS AND THEIR RESPECTIVE HEIRS AND ASSIGNS, BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, SPECIAL (INCLUDING LOSS OF PROFIT), PUNITIVE, OR OTHER DAMAGES ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THE SITE, REGARDLESS OF WHETHER ALLERGAN, LASH OR ANY OF THE OTHER ENTITIES OR PERSONS LISTED ABOVE HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES. THIS INCLUDES DAMAGES TO, OR FOR VIRUSES THAT MAY INFECT, YOUR COMPUTER EQUIPMENT. WITHOUT LIMITING THE FOREGOING, EVERYTHING ON THE SITE IS PROVIDED TO YOU "AS IS" AND "AS AVAILABLE" BASIS, AND ALLERGAN AND LASH MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE WITH RESPECT TO THE SITE. ALLERGAN AND LASH HEREBY DISCLAIM ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, OR NON-INFRINGEMENT. ALLERGAN AND LASH MAKE NO WARRANTY THAT THE SITE WILL MEET YOUR REQUIREMENTS, OR WILL BE UNINTERRUPTED, TIMELY, SECURE, CURRENT, ACCURATE, COMPLETE OR ERROR-FREE OR THAT THE RESULTS THAT MAY BE OBTAINED BY USE OF THE SITE WILL BE ACCURATE OR RELIABLE. IN ADDITION, NEITHER ALLERGAN OR LASH MAKE ANY WARRANTY WITH RESPECT TO THE INTEROPERABILITY OF ANY SYSTEM WITH THE SITE, INCLUDING, WITHOUT LIMITATION, ANY SYSTEM USED BY YOU OR ANY PAYER, WHETHER PROVIDED BY A THIRD PARTY LICENSOR OR OTHERWISE. Please note that some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you. Check your local laws for any restrictions or limitations regarding the exclusion of implied warranties. YOU UNDERSTAND AND ACKNOWLEDGE THAT YOUR SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO ANY DEFECT IN OR DISSATISFACTION WITH THE SITE IS TO CEASE TO USE THE SITE. YOU MAY HAVE OTHER RIGHTS WHICH MAY VARY FROM STATE TO STATE.
No information in the Site is provided with the intention to give medical advice or instructions on the accurate use of Allergan products. Allergan cannot answer e-mails or other correspondence requesting personal medical advice.
Compliance with HIPAA and the HITECH Act
The Site serves as a portal by which Lash performs services as a health care clearinghouse as defined under HIPAA. Allergan is not a health care clearinghouse and all health care clearinghouse services are provided directly by Lash (or other third parties through Lash). Allergan does not provide any of the e-Patient Management Services. The Site may collect, use and disclose de-identified health claims data and create de-identified data from identifiable data for aggregated and statistical purposes.
To the extent you are a covered entity under HIPAA and provide PHI to Lash to perform the e-Patient Management Services, Lash may be a business associate of yours, and thus the following terms are applicable:
Permitted Uses and Disclosures of PHI by Lash.
Unless otherwise limited herein, Lash may, consistent with applicable laws:
- Use the PHI in its possession if necessary (i) for its proper management and administration and/or (ii) to carry out any present or future legal responsibilities of Lash provided that such uses are permitted under state and federal confidentiality laws.
- Disclose the PHI in its possession to third parties for the purpose of its proper management and administration and/or to carry out any present or future legal responsibilities of Lash, provided that that (i) the disclosures are Required by Law; or (ii) Lash has received from the third party written assurances regarding its confidential handling of such PHI as required under HIPAA, and the third party notifies Lash of any breaches in the confidentiality of the PHI.
In addition to using and disclosing the PHI to perform the e-Patient Management Services and the purposes above, Lash may:
Privacy Rule and HITECH Act Responsibilities of Lash.
- Use and/or disclose PHI to report violations of law to appropriate federal and state authorities, consistent with applicable laws.
With regard to its use and/or disclosure of PHI, Lash agrees to:
Security Rule and HITECH Act Responsibilities of Lash.
- Establish procedures for mitigating, to the extent practicable, any deleterious effects from any improper use and/or disclosure of PHI that Lash reports to you.
- Use commercially reasonable efforts and safeguards to maintain the security of the PHI and to prevent unauthorized use and/or disclosure of such PHI.
- Make available all records, books, agreements, policies and procedures relating to the use and/or disclosure of PHI to the Secretary of the Department of Health & Human Services ("HHS") for purposes of determining your compliance with HIPAA, subject to attorney-client and other applicable legal privileges.
- Within fifteen (15) days of receiving a written request from you, provide to you such information as is reasonably requested by you to permit you to respond to a request by an Individual to inspect and obtain a copy of PHI about the Individual that is maintained in a Designated Record Set, for as long as the PHI is maintained in the Designated Record Set; to amend PHI or a record about the Individual in a Designated Record Set, for as long as PHI is maintained in the Designated Record Set; and for an accounting of the disclosures of the Individual's PHI.
- Disclose to its subcontractors, agents or other third parties, and request from you, only the minimum PHI necessary to perform or fulfill a specific function required or permitted hereunder.
With regard to its use and/or disclosure of ePHI, Lash agrees to:
Breach Notification Rule Responsibilities of Lash
- Ensure that any agent, including a subcontractor, to whom it provides such ePHI agrees to implement reasonable and appropriate safeguards to protect it.
- Report to you any Security Incident of which it becomes aware that involves the Confidentiality, Integrity or Availability of the ePHI that it creates, receives, maintains or transmits for or on behalf of you, provided, however, that trivial, non-material attempts to penetrate Lash's networks or systems that occur on a daily basis, such as scans, "pings" or other unsuccessful attempts to penetrate such computer networks or systems, will not be reported.
To the extent Lash accesses, maintains, retains, modifies, records, stores, destroys or otherwise holds, uses or discloses Unsecured PHI, it will, following the discovery of a Breach of such information, notify you within fifteen (15) days of such Breach. Any such notice will include, to the extent possible, the identification of each Individual whose Unsecured PHI has been, or is reasonably believed by Lash, to have been accessed, acquired or disclosed during such Breach. Lash will also provide to you other available information that you are required to include in your notification to the Individual.
Additional HIPAA and HITECH Act Provisions.
Non-identifiable Data and How We Use It
Except with respect to personally identifiable information, any communication or material that you transmit to, or post on, the Site by electronic mail or otherwise, including any data, questions, comments, suggestions, or the like, is, and will be treated as, nonconfidential and nonproprietary information, and neither Allergan nor Lash shall have any obligation of any kind with respect to such information. Allergan, Lash and any of our affiliates may use such information for any purpose whatsoever, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast, and further posting. Further, Allergan, Lash and any of our affiliates shall be free to use such information, including, but not limited to, any ideas, concepts, know-how, or techniques contained therein, for any purpose whatsoever, including, but not limited to, researching, developing, manufacturing, and marketing products incorporating such information.
The Site and its contents are intended for use by licensed physicians (and their staff) within the United States.
This Web site may contain links to other Web sites. Allergan is not responsible for and does not control the contents or performance of such Web sites, and accepts no responsibility for the consequences of your use thereof.
The Site may contain information that is forward-looking and involve risks and uncertainties, including, without limitation, risks and uncertainties of research and development, clinical development, regulatory approvals, our reliance on third-party manufacturers, product commercialization, competition, patents, product liability, and third-party reimbursement, and other risks and uncertainties detailed from time to time in Allergan's periodic reports filed with the Securities and Exchange Commission. Actual results may differ from the forward-looking information.
Jurisdiction and Venue
Upper Limb Spasticity
BOTOX® for injection is indicated for the treatment of upper limb spasticity in adult patients to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), and finger flexors (flexor digitorum profundus and flexor digitorum sublimis).
Safety and effectiveness of BOTOX®
have not been established for the treatment of other upper limb muscle groups, or for the treatment of lower limb spasticity. Safety and effectiveness of BOTOX®
have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX®
has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX®
is not intended to substitute for usual standard of care rehabilitation regimens.
is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
Blepharospasm and Strabismus
is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
Primary Axillary Hyperhidrosis
is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
IMPORTANT SAFETY INFORMATION
Distant Spread of Toxin Effect|
Postmarketing reports indicate that the effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX®
are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX®
cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
See Boxed Warning.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX®
should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent, and consequently the causal agent cannot be reliably determined.
Pre-Existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX®
The following adverse reactions to BOTOX®
for injection are discussed in greater detail in the following sections: Spread of Toxin Effect (see Boxed Warning); Hypersensitivity Reactions (see Contraindications and Warnings and Precautions);
Post Marketing Experience
There have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin. There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.
Please see BOTOX®
full prescribing information
, including Medication Guide